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CTD and eCTD



Girish Swami,   (M.Pharm, PGDIPR, PGDDRA)

                International Regulatory Affairs Dept.
                                g      y           p

                +91-9881492626

                pr.girish@gmail.com
What is CTD/eCTD ?
   Common Technical Document (CTD): Its an
   format set by ICH which was agreed by the
   Regulatory Agencies of Europe, Japan & the US.




   Its electronic version called as
   electronic Common Technical Document
   (eCTD).


Girish Swami, M.Pharm, PGDIPR, PGDDRA       Page 2 of 20
The CTD Triangle




Girish Swami, M.Pharm, PGDIPR, PGDDRA   Page 3 of 20
CTD Modules
       Module 1 – Administrative Information
                  (Region Specific)

       Module 2 – CTD Summaries (QOS)

       Module 3 – Quality (CMC)

       Module 4 – Non-Clinical Study Reports
                                   y   p

       Module 5 – Clinical Study Reports


Girish Swami, M.Pharm, PGDIPR, PGDDRA          Page 4 of 20
Module 1
  Administrative Information (Region Specific)
  Should contain documents specific to each region
  For USA                               For EU
     Application form 356h                 Application form
     Proposed l b l
             d label                       Summary of product characteristics
     Patent certification /                Labelling text and mock-ups
     information                           Information about the experts
     Debarment certificate
                                           Environmental risk assessment
     Letter of Authorization
     (LoA)/ DMF letter                     Description of the
                                           pharmacovigilance system
     Labeling text
                                           Risk management plan




Girish Swami, M.Pharm, PGDIPR, PGDDRA                             Page 5 of 20
Module 2
   odu e
  CTD Summaries (QOS)

 It contain 7 sections in the following order:
            2.1 CTD TOC (Module 2-5)
            2.2
            2 2 CTD Introduction
            2.3 Quality Overall Summary
            2.4 Non-clinical
            2 4 Non clinical Overview
            2.5 Clinical Overview
            2.6 Non-Clinical
            2 6 Non Clinical Summary
            2.7 Clinical Summary



Girish Swami, M.Pharm, PGDIPR, PGDDRA            Page 6 of 20
Module 3
  Quality (CMC)

       3.1
       3 1 TOC of M d l 3
                f Module
       3.2 Body of Data
             3.2.S - Drug substance
             3.2.P - Drug product
             3.2.A - Appendices
                           d
             3.2.R - Regional Information
       3.3
       3 3 Literature references
                        f



Girish Swami, M.Pharm, PGDIPR, PGDDRA       Page 7 of 20
Module 4
  Non-Clinical Study Reports
       4.1
       4 1 TOC of M d l 4
                f Module
       4.2 Study reports
           4.2.1 Pharmacology
           4.2.2 Pharmacokinetics
           4.2.3 Toxicology
                       l
       4.3 Literature References




Girish Swami, M.Pharm, PGDIPR, PGDDRA   Page 8 of 20
Module 5
  Clinical Study Reports
     5.1
     5 1 TOC of Module 5
     5.2 Tabular listing of Clinical Studies
     5.3 Clinical study reports
         5.3.1    Reports of Biopharmaceutical (BA-BE) Study
         5.3.2    Reports of Pharmacokinetic (biomaterial) study
         5.3.3    Reports of Pharmacokinetic (PK) Studies
         5.3.4    Reports of Pharmacodynamic (PD) Studies
         5.3.5    Reports of Efficacy and Safety studies
         5.3.6    Reports of Post-Marketing experience
                    p                      g   p
         5.3.7    Case Report Forms & Individual patient listings
     5.4 Literature References


Girish Swami, M.Pharm, PGDIPR, PGDDRA                     Page 9 of 20
eCTD
             Its electronic version of CTD so called as
                                       CTD,
              electronic Common Technical Document
                               (eCTD).

       eCTD composed of two types of specification
             Content specification – As defined by ICH
                      p                            y
             Technical specification – Electronic software's




Girish Swami, M.Pharm, PGDIPR, PGDDRA                          Page 10 of 20
eCTD is highly recommended by USFDA for
       NDAs, BLAs, DMFs and INDs filing
       From year 2010 European Union also make
            y               p
       compulsory for electronic CTD submission to all
       procedures




Girish Swami, M.Pharm, PGDIPR, PGDDRA            Page 11 of 20
eCTD Characteristics
Structure
          All Modules 1 to 5 have granularity
          options.
          PDF documents linked via XML
          backbone
          Increased document granularity
                               granularity.
          Transparency of entire submission
          Ease of navigation and review




Girish Swami, M.Pharm, PGDIPR, PGDDRA           Page 12 of 20
eCTD Template




Girish Swami, M.Pharm, PGDIPR, PGDDRA   Page 13 of 20
M1




Girish Swami, M.Pharm, PGDIPR, PGDDRA   Page 14 of 20
M2




Girish Swami, M.Pharm, PGDIPR, PGDDRA   Page 15 of 20
M3




Girish Swami, M.Pharm, PGDIPR, PGDDRA   Page 16 of 20
M4




Girish Swami, M.Pharm, PGDIPR, PGDDRA   Page 17 of 20
M5




Girish Swami, M.Pharm, PGDIPR, PGDDRA   Page 18 of 20
Benefits of eCTD




Girish Swami, M.Pharm, PGDIPR, PGDDRA   Page 19 of 20
Thank
                             Th k you




Girish Swami, M.Pharm, PGDIPR, PGDDRA   Page 20 of 20

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CTD and eCTD

  • 1. CTD and eCTD Girish Swami, (M.Pharm, PGDIPR, PGDDRA) International Regulatory Affairs Dept. g y p +91-9881492626 pr.girish@gmail.com
  • 2. What is CTD/eCTD ? Common Technical Document (CTD): Its an format set by ICH which was agreed by the Regulatory Agencies of Europe, Japan & the US. Its electronic version called as electronic Common Technical Document (eCTD). Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 2 of 20
  • 3. The CTD Triangle Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 3 of 20
  • 4. CTD Modules Module 1 – Administrative Information (Region Specific) Module 2 – CTD Summaries (QOS) Module 3 – Quality (CMC) Module 4 – Non-Clinical Study Reports y p Module 5 – Clinical Study Reports Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 4 of 20
  • 5. Module 1 Administrative Information (Region Specific) Should contain documents specific to each region For USA For EU Application form 356h Application form Proposed l b l d label Summary of product characteristics Patent certification / Labelling text and mock-ups information Information about the experts Debarment certificate Environmental risk assessment Letter of Authorization (LoA)/ DMF letter Description of the pharmacovigilance system Labeling text Risk management plan Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 5 of 20
  • 6. Module 2 odu e CTD Summaries (QOS) It contain 7 sections in the following order: 2.1 CTD TOC (Module 2-5) 2.2 2 2 CTD Introduction 2.3 Quality Overall Summary 2.4 Non-clinical 2 4 Non clinical Overview 2.5 Clinical Overview 2.6 Non-Clinical 2 6 Non Clinical Summary 2.7 Clinical Summary Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 6 of 20
  • 7. Module 3 Quality (CMC) 3.1 3 1 TOC of M d l 3 f Module 3.2 Body of Data 3.2.S - Drug substance 3.2.P - Drug product 3.2.A - Appendices d 3.2.R - Regional Information 3.3 3 3 Literature references f Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 7 of 20
  • 8. Module 4 Non-Clinical Study Reports 4.1 4 1 TOC of M d l 4 f Module 4.2 Study reports 4.2.1 Pharmacology 4.2.2 Pharmacokinetics 4.2.3 Toxicology l 4.3 Literature References Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 8 of 20
  • 9. Module 5 Clinical Study Reports 5.1 5 1 TOC of Module 5 5.2 Tabular listing of Clinical Studies 5.3 Clinical study reports 5.3.1 Reports of Biopharmaceutical (BA-BE) Study 5.3.2 Reports of Pharmacokinetic (biomaterial) study 5.3.3 Reports of Pharmacokinetic (PK) Studies 5.3.4 Reports of Pharmacodynamic (PD) Studies 5.3.5 Reports of Efficacy and Safety studies 5.3.6 Reports of Post-Marketing experience p g p 5.3.7 Case Report Forms & Individual patient listings 5.4 Literature References Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 9 of 20
  • 10. eCTD Its electronic version of CTD so called as CTD, electronic Common Technical Document (eCTD). eCTD composed of two types of specification Content specification – As defined by ICH p y Technical specification – Electronic software's Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 10 of 20
  • 11. eCTD is highly recommended by USFDA for NDAs, BLAs, DMFs and INDs filing From year 2010 European Union also make y p compulsory for electronic CTD submission to all procedures Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 11 of 20
  • 12. eCTD Characteristics Structure All Modules 1 to 5 have granularity options. PDF documents linked via XML backbone Increased document granularity granularity. Transparency of entire submission Ease of navigation and review Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 12 of 20
  • 13. eCTD Template Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 13 of 20
  • 14. M1 Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 14 of 20
  • 15. M2 Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 15 of 20
  • 16. M3 Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 16 of 20
  • 17. M4 Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 17 of 20
  • 18. M5 Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 18 of 20
  • 19. Benefits of eCTD Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 19 of 20
  • 20. Thank Th k you Girish Swami, M.Pharm, PGDIPR, PGDDRA Page 20 of 20